NCT06159907

Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Gynecological Tumors.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 380 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

Gynecological cancers involve several tumors of the female reproductive system. The five most common gynecological tumors are those of the uterine cervix, endometrium, ovary, vagina and vulva. Furthermore, although rarer, there is a further gynecological tumor, which is generated from the gestational trophoblast tissue.These pathologies represent an important burden for society since there are over nine hundred thousand cases in Europe. Ultrasound examination is the investigation commonly used to monitor high-risk women. Magnetic resonance imaging (MRI) is considered the most accurate imaging technique for presurgical staging of gynecological tumors. Computed tomography (CT), on the other hand, is not usually used for diagnosis, but is considered very useful for investigating possible distant metastases.Finally, integrated positron emission tomography (PET)/CT and PET/MRI methods are innovative molecular imaging techniques and represent a continually expanding field of research in the oncology setting, including gynecological malignancies. The present study is of considerable clinical relevance as at our Institute it is possible to have a significant number of patients suffering from gynecological neoplastic pathologies that are studied using PET, thus allowing the identification and validation of innovative imaging biomarkers, with the use of both traditional imaging parameters and radiomic features.

Conditions

• Gynecological Tumors

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	the diagnostic and prognostic value of PET/MRI and PET/CT with 18F-FDG in patients presenting with gynecological tumors	For the evaluation of patients affected by endometrial cancer, the correlations between semi-quantitative PET parameters (SUVmax, SUVmean, MTV and TLG calculated at different SUVmax thresholds) and histological data, such as for example myometrial invasion, will be investigated. lymph node invasion, tumor grade and type, risk level, probability of mutation of the p53 gene, etc. In addition to traditional imaging parameters we will also investigate the usefulness of radiomic features, i.e. quantitative data extracted from PET images (PET/CT or PET/MRI), in predicting and explaining histological data

Timeline

• Start date: 2021-10-27
• Primary completion: 2024-12-27
• Completion: 2024-12-27
• First posted: 2023-12-07
• Last updated: 2024-03-06

Locations

1 site across 1 country: Italy